Patient leaflet - Melatonin Evolan 4 mg film-coated tablet
1. What Melatonin Evolan is and what it is used for
The active substance of Melatonin Evolan, melatonin, belongs to a group of natural hormones produced by the body. The hormo-ne helps regulate the body’s day- and night rhythm.
Melatonin Evolan is used for:
- insomnia in children and adolescents (6 to 17 years old) with ADHD, where other healthy sleeping routines have not worked well enough.
- short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by the time difference when traveling across several time zones.
2. What you need to know before
you take Melatonin Evolan Do not take Melatonin Evolan:
- if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Melatonin Evolan if you have:
- diabetes or impaired glucose tolerance, as this medicine may increase the level of glucose in your blood
- liver or kidney problems
- an autoimmune disease (where the body is ‘attacked’ by its own immune system)
- epilepsy
- or if you are elderly
Melatonin Evolan can make you feel drowsy. You should be careful if drowsiness affects you, as it may impair your ability to perform tasks such as driving.
Smoking
Smoking can decrease the effect of mela- tonin. If you smoke, start or stop smoking, your doctor may need to adjust your dose. Melatonin Evolan with food and alcohol
Food should not be consumed 2 hours before or 2 hours after taking melatonin. Do not drink alcohol in connection with taking Melatonin Evolan, as it may reduce the effect of melatonin on sleep.
Children and adolescents
Melatonin Evolan should not be given to children below the age of 6 years.
Other medicines and Melatonin Evolan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If Melatonin Evolan is taken at the same time as the following medicines, it can affect the way that Melatonin Evolan or the other medicine works:
- Depression (e.g. fluvoxamine, citalopram)
- Sleep disorder (e.g. zolpidem)
- Epilepsy (carbamazepine, phenytoin)
- Ulcers (cimetidine, omeprazole, lansoprazole)
- Skin disorders (psoralens)
- Heart conditions (verapamil)
- High blood pressure (nifedipine, beta- blockers)
Bacterial infections (rifampicin, ciprofloxacin
and norfloxacin)
- Prevention and treatment of blood clots (warfarin)
- Contraceptives containing ethinylestradiol and gestagen
- Hormone replacement therapy due to menopause problems
- Pain and inflammation (non-steroidal anti-inflammatory medicines, e.g. acetyl- salicylic acid and ibuprofen)
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should not use Melatonin Evolan. Pregnancy
Melatonin Evolan is not recommended if you are pregnant. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child. If you are woman of childbearing potential you have to use contraception.
Breast-feeding
Melatonin Evolan is not recommended if you are breast-feeding. Melatonin is excreted in human milk, and a risk to the breast-fed child cannot be excluded.
Fertility
Melatonin Evolan is not recommended in women and men planning to have a baby as there is insufficient information on the effects of melatonin on female and male fertility. Driving and using machines
Melatonin Evolan can make you feel drowsy. If this happens, you must not drive or operate machinery.
3. How to take Melatonin Evolan
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you have impaired kidney function or are elderly, your doctor may need to reduce your dose.
Children and adolescents aged 6-17 years old with ADHD with insomnia
The recommended starting dose is 1 to 2 mg 30-60 minutes before bedtime. If there is no improvement in your/your child’s symptoms, your doctor may increase the dose of Melatonin Evolan to find the most suitable dose for you/ your child. The maximum daily dose that you/ your child will receive is 5 mg.
Treatment should be followed up regularly by a doctor (at least every 6 months is recommen-ded) to see if it is still appropriate. Treatment should be interrupted once a year to see if treatment is still needed.
Adults with jet lag
The recommended dose is 1 to 5 mg for a maximum of 5 days.
Take the dose at the time of bedtime at the destination, when traveling over at least 5 time zones, especially for trips in an easterly direction. The tablets should not be taken before 20:00 hr or after 04:00 hr.
Melatonin Evolan for treatment of jet lag may be taken for a maximum of 16 treat-ment periods per year.
How to take Melatonin Evolan
The tablet can be swallowed whole or crushed before intake and mixed with water. The 2 mg and 5 mg tablets can be divided into two equal doses while the other strengths are not divisible.
If you take more Melatonin Evolan than you should
If you or your child has accidentally taken too much medicine or if for example a child has ingested the medicine by mistake, contact a doctor, hospital or pharmacist as soon as possible.
Taking more than the recommended daily dose may make you feel drowsy.
If you forget to take Melatonin Evolan
If you forget to take a dose at bedtime and wake during the night you may take the for-gotten dose but at no later than 04:00 hr. Do not take a double dose to make up for a forgotten dose.
If you stop taking Melatonin Evolan
There are no known harmful effects if treatment is interrupted or ended. The use of Melatonin Evolan is not known to cause any withdrawal effects after treatment comple-tion.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Melatonin Evolan and contact a doctor immediately:
Frequency not known (cannot be established from the available data):
- Hypersensitivity reaction, swelling of face, swelling of mouth, swelling of tongue
- Chest pain
Other side effects:
Common side effects: may affect up to 1 in 10 people
- Headache
- Sleepiness
Uncommon side effects: may affect up to 1 in 100 people
- Irritability, nervousness, restlessness, anxiety
- Insomnia, abnormal dreams, nightmares
- Migraine, dizziness, nausea
- Lethargy (tiredness) and lack of energy, rest-lessness associated with increased activity
- High blood pressure
- Abdominal pain, indigestion, mouth ulcera-tion, dry mouth
- Changes in the composition of your blood which can cause yellowing of the skin and eyes
- Inflammation of the skin, itching, rash, dry skin, night sweats
- Pain in arms and legs
- Excretion of glucose in the urine, excess proteins in the urine
- Menopausal symptoms
- Feeling of weakness, chest pain
- Weight gain
Rare side effects: may affect up to 1 in 1000 people
- Shingles
- Reduced number of white blood cells in the blood
- Reduced number of blood platelets
- Low calcium or sodium levels in the blood
- High level of blood fats
- Altered mood, aggression, restlessness asso-ciated with increased activity, crying, stress symptoms, disorientation, early morning awakening, increased sex drive, depressed mood, depression
- Fainting, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles’ feeling, hallucinations
- Visual impairment, blurred vision, watery eyes
- Vertigo (a feeling of dizziness or “spinning”), dizziness when standing or sitting
- Chest pain due to angina, feeling your heartbeat
- Hot flushes
- Acid reflux, gastrointestinal disorder, blistering in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, wind, excess saliva production, bad breath, abdominal discomfort, inflamma-tion of the stomach lining
- Eczema, skin rash, hand dermatitis, itchy rash, psoriasis, nail disorder
- Arthritis, muscle spasms, neck pain, night cramps
- Passing large volumes of urine, urinating during the night, presence of red blood cells in the urine
Prolonged erection - that might be painful
- without sexual stimulation, inflammation of the prostate gland
- Tiredness, pain, thirst
- Increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests Frequency not known: cannot be established from the available data
- Abnormal milk secretion
- Hallucinations (e.g. seeing, feeling or hearing things that don’t exist)
- High blood glucose level
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: www.mhra. gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medi- cine. 2195-1
5. How to store Melatonin Evolan
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via waste- water or household waste. Ask your pharma-cist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Melatonin Evolan contains
- The active substance is melatonin 2 mg, 3 mg, 4 mg or 5 mg.
- The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol/ PEG 3350, talc.
What Melatonin Evolan looks like and contents of the pack
2 mg: white, round, biconvex film-coated tablet, diameter 7 mm, scored and marked M2. The tablet can be divided into two equal doses.
3 mg: white, round, biconvex film-coated tablet, diameter 9 mm, scored and marked M3. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 mg: white, round, biconvex film-coated tablet, diameter 11 mm, marked M4. 5 mg: white, round, biconvex film-coated tablet, diameter 12 mm, scored and marked M5. The tablet can be divided into two equal doses.
Package sizes:
Blister (Al/PVC) containing 10, 20, 30, 40, 50, 56, 70, 90, 100, 105, 200 or 300 film-coated tablets.
White plastic bottle with white plastic lid containing 30,50, 56, 90, 100, 105, 200 (2 x 100) or 300 (3 x 100) film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder
Evolan Pharma AB
P.O. Box 120
SE-182 12 Danderyd
Sweden
Manufacturer
S.C. Laropharm S.R.L,
145 A Alexandriei street,
Bragadiru, Ilfov, 077025,
Romania
This leaflet was last revised in July 2026
If you would like any more informa-tion, or would like the leaflet in a different format, please contact the Marketing Authorisation Holder at the above address or mail to info@evolan.se.